US Covid-19 test authorisations slow as UK runs into trouble
The FDA has now granted emergency use authorisation to around 250 Covid-19 tests or related technologies, and as efforts begin to focus more on the logistics of getting the authorised assays to the people who need them, the rate of authorisations appears to be tailing off. Just one test for the coronavirus was granted the go-ahead last week: Agena Bioscience’s MassArray Sars-Cov-2 panel, a molecular assay. Across the pond, it has emerged that a rapid antigen test bought in large numbers by the UK government cannot be used as intended. The Sars-Cov-2 Antigen Rapid Qualitative Test is, according to its instructions for use, only suitable for use in patients with Covid-19 symptoms. The UK government bought 20 million of these tests in October with the intention of using them to screen asymptomatic people. The test is distributed in the UK by Tried and Tested but is made by the Chinese company Xiamen Biotime Biotechnology for Innova Medical Group under a partnership signed in the summer. Innova is owned by the LA-based investment company Pasaca Capital, whereas according to its website, Tried and Tested is the trading name of Disruptive Nanotechnology, a UK company based in Northamptonshire.
Note: "Other" includes six antigen tests, five home sampling kits, three saliva collection devices and two IL-6 tests.